FDA recall Z-2278-2019

Pega Medical Inc. · Class II · device

Product

SLIM Handle - catalogue #: SLM-HND100 a component of Simple Locking Intramedullary (SLIM) System

Reason for recall

Handle could jam with the Driver due to the detachment of an internal Connector Ring.

Distribution

CA, DE, FL, IL, NC, NE, NY and TN

Key facts

Status
Terminated
Initiation date
2019-05-29
Report date
2019-08-21
Termination date
2021-01-15
Voluntary/Mandated
Voluntary: Firm initiated
Location
Laval, N/A, Canada

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2278-2019